OBJECTIVE: To evaluate whether weaning protocols are superior to standard care (no defined protocol) for infants and children with acute illnesses requiring mechanical ventilator support and whether a volume support weaning protocol using continuous automated adjustment of pressure support by the ventilator (ie, VSV) is superior to manual adjustment of pressure support by clinicians (ie, PSV). DESIGN AND SETTING: Randomized controlled trial conducted in the pediatric intensive care units of 10 children's hospitals across North America from November 1999 through April 2001. PATIENTS: One hundred eighty-two spontaneously breathing children (< 18 years old) who had been receiving ventilator support for more than 24 hours and who failed a test for extubation readiness on minimal pressure support. INTERVENTIONS: Patients were randomized to a PSV protocol (n = 62), VSV protocol (n = 60), or no protocol (n = 60). MAIN OUTCOME MEASURES: Duration of weaning time (from randomization to successful extubation); extubation failure (any invasive or noninvasive ventilator support within 48 hours of extubation). RESULTS: Extubation failure rates were not significantly different for PSV (15%), VSV (24%), and no protocol (17%) (p = 0.44). Among weaning successes, median duration of weaning was not significantly different for PSV (1.6 days), VSV (1.8 days), and no protocol (2.0 days) (p = 0.75). Male children more frequently failed extubation (odds ratio 7.86; 95% confidence interval 2.36 to 26.2; p < 0.001). Increased sedative use in the first 24 hours of weaning predicted extubation failure (p = 0.04) and, among extubation successes, duration of weaning (p < 0.001). CONCLUSIONS: In contrast with adult patients, the majority of children are weaned from mechanical ventilator support in 2 days or less. Weaning protocols did not significantly shorten this brief duration of weaning.

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